Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer
Conditions
Mucositis - Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms - Mucositis
Conditions: Keywords
mucositis, head and neck, cancer, radiation therapy, chemoradiation, oral, pain
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: Ketamine Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
Summary
- The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis.

- The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Subjects diagnosed with head and neck tumors (any histology) receiving ongoing chemoradiation or radiation therapy

- Subjects with mucositis pain refractory to topical management, defined as any self-reported pain score of > 2 in the 24 hours prior to enrollment despite use of topical agents as prescribed

- Age ≥ 18 years

- Ability to understand and willingness to consent and to sign consent form

Exclusion Criteria:

- Active substance abuse at time of registration (alcohol, drugs, non-prescription use of controlled substances)

- Subjects with history of allergic reactions to ketamine

- Persistent oral bleeding: > 15 mL (estimated) per day

- Pregnancy or breast feeding
Location
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Research Nurse - 800-639-6918 - cancer.research.nurse@dartmouth.edu
Start Date
June 2010
Completion Date
January 2016
Sponsors
Dartmouth-Hitchcock Medical Center
Source
Dartmouth-Hitchcock Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page